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Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations will be conducted every 3-6 months, and blood samples will be retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.
Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. Group A has an anti HBs titer ≥ 100mIU/ml and is followed up every 3-6 months for observation. The anti HBs titers<100mIU/ml were randomly divided into two groups: Group B and Group C. Group B did not intervene and was followed up every 3-6 months for observation; In group C, 20 micrograms of recombinant hepatitis B vaccine were injected subcutaneously three times on day 0, January and March. For group C patients, the level of anti HBs was detected at the 4th month after the initial vaccination. For those who could not produce anti HBs (anti HBs<10mIU/ml), the recombinant hepatitis B vaccine was subcutaneously injected three times, 20 μ g each time, in 0 day, January and March. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations were conducted every 3-6 months, and blood samples were retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A:baseline anti-HBs titer≥100 mIU/ml | No Intervention | Patients with anti-HBs titer ≥100 mIU/ml at baseline were selected as group A | |
| Group B:baseline anti-HBs titer<100 mIU/ml | No Intervention | Patients with anti-HBs titer<100 mIU/ml at baseline were randomly divided into group B and group C, and group B did not receive intervention | |
| Group C:baseline anti-HBs titer<100 mIU/ml | Experimental | Patients with anti-HBs titer<100 mIU/ml at baseline were randomly divided into group B and group C, and group C received hepatitis B vaccine injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| baseline anti-HBs titer | Biological | Patients with baseline anti-HBs titer<100 mIU/ml were randomly divided into two groups, group B and group C. Group B did not intervene, while group C received hepatitis B vaccine intervention and observed its indicators. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained response rate and relapse rate by virological and serological indicators | The levels of biochemical, AFP, HBV DNA, HBV RNA, HBsAg, anti-HBs, HBeAg, anti-He, anti-He, HBcrAg and anti-HBc measured the expression of frequency and functional molecules of peripheral blood pDC and Treg cells and the plasma levels of IFN- γ, IP-10, IL-10 and TGF- β | Conduct testing every 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of hepatitis and liver cancer | The incidence of hepatitis and liver cancer among the enrolled researchers during the research process The incidence of hepatitis and liver cancer among the enrolled researchers during the research process The incidence of hepatitis and liver cancer among the enrolled researchers during the research process. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Zhang | Contact | 13581975577 | zhanglu1218@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Minghui Li | Beijing Ditan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |